CADX»Topics» Delays in the commencement or completion of clinical testing could result in increased costs to us and delay or limit our ability to obtain regulatory approval for our product candidates.

Delays
in the commencement or completion of clinical testing could
result in increased costs to us and delay or limit our ability
to obtain regulatory approval for our product
candidates.

Delays in the commencement or completion of clinical testing
could significantly affect our product development costs. We do
not know whether planned clinical trials for IV APAP will
be completed on schedule, if at all. Additionally, the
still-to-be-initiated
clinical trials for IV APAP may not begin on time.
Similarly, we may not complete enrollment for our ongoing
Phase III clinical trial for Omigard on schedule, or at
all. The commencement and completion of clinical trials requires
us to identify and maintain a sufficient number of trial sites,
many of which may already be engaged in other clinical trial
programs for the same indication as our product candidates or
may not be eligible to participate in or may be required to
withdraw from a clinical trial as a result of changing standards
of care. The commencement and completion of clinical trials can
be delayed for a variety of other reasons, including delays
related to:



reaching agreements on acceptable terms with prospective
clinical research organizations, or CROs, and trial sites, the
terms of which can be subject to extensive negotiation and may
vary significantly among different CROs and trial sites;

recruiting and enrolling patients to participate in clinical
trials for a variety of reasons, including competition from
other clinical trial programs for the same indication as our
product candidates; and



retaining patients who have initiated a clinical trial but may
be prone to withdraw due to the treatment protocol, lack of
efficacy, personal issues, side effects from the therapy or who
are lost to further
follow-up.

In addition, a clinical trial may be suspended or terminated by
us, the FDA or other regulatory authorities due to a number of
factors, including:



failure to conduct the clinical trial in accordance with
regulatory requirements or our clinical protocols;



inspection of the clinical trial operations or trial sites by
the FDA or other regulatory authorities resulting in the
imposition of a clinical hold;



new information suggesting unacceptable risk to subjects, or
unforeseen safety issues or any determination that a trial
presents unacceptable health risks; or



lack of adequate funding to continue the clinical trial,
including the incurrence of unforeseen costs due to enrollment
delays, requirements to conduct additional trials and studies
and increased expenses associated with the services of our CROs
and other third parties.

Additionally, changes in regulatory requirements and guidance
may occur and we may need to amend clinical trial protocols to
reflect these changes. Amendments may require us to resubmit our
clinical trial protocols to institutional review boards for
reexamination, which may impact the costs, timing or successful
completion of a clinical trial. If we experience delays in the
completion of, or if we terminate, our clinical trials, the
commercial prospects for our product candidates will be harmed,
and our ability to generate product revenues will be delayed. In
addition, many of the factors that cause, or lead to, a delay in
the commencement or completion of clinical trials may also
ultimately lead to the denial of regulatory approval of a
product candidate. Even if we are able to ultimately
commercialize our product candidates, other therapies for the
same indications may have been introduced to the market and
established a competitive advantage.